Regulatory Affairs Publishing Consultant

A global pharmaceutical research company is seeking to recruit an Operations Analyst to their office in Madrid. The organisation is known for its work in consultation and development across market research across the healthcare industry, particularly relating to industry and medicinal products. This is an extremely exciting opportunity to work with an international establishment and bolster a career in the pharmaceutical industry. The Operations Analyst will closely participate in the operational management of the company, according to company policies and profit forecast/goals.

Job Responsibilities:

• Able to independently format, publish, transmit and archive all submission types.
• Planning, publishing (eCTD), reviewing and delivery of lifecycle submissions to Health Authorities within required timelines.

• Able to answer technical questions for many submission types.
• Attend Regulatory Submission team meetings, and act as the publishing SME on behalf of the Regulatory Operations function.
• Able to answer technical questions for many submission types.

• Uses professional concepts and company's policies and procedures to solve a wide range of moderate problems in imaginative and practical ways.
• Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Skills and Requirements:

• At least 3 years of experience in Regulatory Operations, and eCTD lifecycle submissions.
• Must be certified in InSight Publisher or be able to provide training completion certificates.
• Advanced understanding of regulations and guidance's associated with submissions, including and most importantly in eCTD and lifecycle submissions.
• Proficiency in publishing eCTD submissions and using related tools, including InSight Publisher and Acrobat plug-ins such as ISI Toolbox.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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